Transforming the Regulatory Environment Through as-a-Service

The cloud is gaining huge ground across all industries as companies seek greater flexibility and reduced costs. Cloud can transform the way life sciences companies maneuver the changing regulatory landscape. But putting an as-a-service or cloud solution in place requires careful consideration, including identifying the stakeholders, defining your reason and goals, establishing a clear plan, and aligning that plan with the overall data and IT strategy.

The first step in building the business case is to bring the decision makers together. IT must be involved since it’s clearly an IT-related project. Some IT departments may still be resistant to off-premises implementation of applications, so you need to define what the benefits are to an IT organization.

From the business side, you need to determine what an as-a-service solution will deliver and make sure these business leaders are involved: regulatory, pharmacovigilance and commercial, as well as senior management.

Clearly, finance needs to be heavily involved in the process since cloud or as-a-service is a mechanism that replaces the standard CAPEX with an ongoing cost, or OPEX.

Stepping Up

Any change will encounter resistance, so you need to be ready to deal with that. IT might see cloud as removing control from its purview, which isn’t necessarily true, but it is moving away from something that they know. Both data and senior management may raise questions about data integrity, security and compliance. Those are the factors you need to highlight constructively.

Finance will have obvious questions about cost. Undoubtedly, it costs money up front to change your IT infrastructure model and embrace cloud, so it’s important to demonstrate that such a change is economically viable. The point about an OPEX model is that it’s not a one-off cost decision, but rather about return on investment. When can you expect to see ROI? And how do you calculate that? It’s unlikely to be instantaneous, but over time as-a-service will provide the business with ROI that enables it to introduce innovations and next-generation solutions that might otherwise have proved difficult to do.

There are many reasons why cloud makes sense and not just because of longer-term ROI. New demands on the business, particularly from a regulatory point of view, require new thinking and new strategies. Take identification of medicinal products (IDMP), for example, and its requirements to integrate data across the enterprise. If you don’t have the resources — both personnel and infrastructure — to manage IDMP, you’ll have to find them. That’s a heavy up-front investment.

If those regulatory changes take place over a period of years — as IDMP is expected to do — you also need to keep pace with those changes. That could require more resources to make sure you’re keeping up with the requirements the authorities are imposing and for frequent revalidation of the platform. That, in itself, could force you to bring in a whole new team, and that team might have little to do once the initial work of preparing for IDMP has been completed.

But as-a-service changes that model substantially, and in a way that’s positive for the business. Rather than forcing the company to set up the infrastructure, you’ll take it as-a-service. While you’ll need some internal experts to tackle the IDMP process, you won’t have to employ lots of new personnel to gather the required data and move it where it needs to be to meet the standards.

Furthermore, if the vendor you select has the right regulatory knowledge to handle IDMP, it will be able to keep up with the changes and even run ahead of them so you’re never caught unprepared. And because your vendor partner will likely be doing this for many companies, you also gain best practices capabilities.

One of the issues with IDMP is that the European Medicines Agency (EMA) has yet to release the guidances, so companies can’t move forward completely. However, waiting is the last thing your company should be doing. You need to take a proactive approach, and having an experienced regulatory cloud partner means that many of those issues will be transferred to your partner. It takes on the responsibility of making sure the data is structured so that changes can be managed relatively easily.

There’s a general feeling across the services industry that if everyone waits to start the IDMP journey, when EMA announces its requirements companies might not have a lot of time. That will put extra stress on organizations, not only to get it done but find the right resources — personnel and infrastructure.

But an as-a-service model takes that stress away because the service is required to make those changes available to your organization, and that ensures you are ahead of the game.

ABOUT THE AUTHOR

DXC Technology brings an independent point of view on transformation and provides unique best-in-class technology, consulting services and insights for life sciences organizations worldwide. DXC aspires to be the life sciences transformation partner of choice. Join the conversation as we discuss the news, trends and technologies transforming the life sciences industry.